CompletedNot Applicable

Transnasal Induction of Normothermia in Febrile Stroke Patients

United States30 participantsStarted 2018-01-16

Plain-language summary

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Admitted to the Neurosciences Critical Care Unit (NCCU).
. Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
. Planned stay in NCCU \> 24 hours.
. Must have informed consent from the patient or the legally authorized representative (LAR)

Exclusion criteria

. Age \< 18 years old or \> 95 years.
. Intubation is contraindicated.
. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
. Hemodynamic instability, including elevated SPB for \>5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
. History of cryoglobulinemia.
. History of sickle cell disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cooling Performance

Timeframe: 4 hours

Trial details

NCT IDNCT03360656

SponsorCoolTech LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-22

Results submitted2023-05-25

View on ClinicalTrials.gov More Stroke, Ischemic trials